FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3103233
·
Received May 9, 2013
Report
- Report Number
- 1823260-2013-02861
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 13, 2013
- Report Date
- July 28, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 582 MG/DL AND 66 MG/DL. CUSTOMER WAS FEELING SYMPTOMS OF HYPOGLYCEMIA AND SELF-TREATED WITH 4 GLUCO-TABS. CUSTOMER THEN SET INSULIN PUMP AT 80% FOR A TEMPORARY BASAL RATE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203459 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 490925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | ACCUCHEK SPIRIT PUMP| ACNEPRIL| DEXCOM CGM| DIOVAN| HUMALOG U100| LEVOTHYROXINE| LORAZEPAM| LYRICA| METOCLOPRAMIDE| TRICOR FENOFIBRATE TABS| ACNEPRIL| METOCLOPRAMIDE| DIOVAN| LEVOTHYROXINE| LYRICA| TRICOR FENOFIBRATE TABS| LORAZEPAM| HUMALOG U100| ACCUCHEK SPIRIT PUMP| DEXCOM CGM |